Treatment Decision Analysis Model for Prostate Cancer: A Randomized Trial

NCT02024685 | Terminated DMC

• 2 other identifiers: CASE19806NCI-2013-02363
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This is a psychosocial/behavioral study and does not involve administration of any treatment or diagnostic procedures. We will use a randomized trial to test the hypothesis that a decision analysis model that provides individualized estimates of quality-adjusted disease-free survival for each of the treatment options for clinically localized prostate cancer will lead to higher quality treatment decisions congruent with a patient's values leading to improved decisional regret and treatment satisfaction. In this trial, all patients would be evaluated at baseline for their utilities for various clinically important health states. The control arm will receive counseling regarding treatment options using standard patient-physician interactions and nomogram-predicted probabilities of treatment outcome for the various treatment options and they will be unaware of the decision analysis recommendation. The treatment arm would be counseled using standard patient-physician interactions and they would also be provided with a personalized treatment recommendations based on the decision analysis model prior to treatment selection. The primary endpoint of this study will be regret-free survival at 2 years after treatment. There will be a 1:1 randomization. A random permuted design will be used to assure approximate balanced number of patients in the two groups over time.

Conditions

Adenocarcinoma of Prostate; Adenocarcinoma of the Prostate Stage I; Adenocarcinoma of the Prostate Stage II; Adenocarcinoma of the Prostate Stage III

Keywords

Prostate; Localized Prostate Cancer; Decision making

Outcome Measures

Primary Outcomes (1)

• Decisional regret

  To see if a decision analysis model that considers individualized predictions of cancer outcome, treatment-related morbidity, and patient-specific values for clinically important health states leads to higher quality treatment decisions patients will take a validated four item questionnaire which is standardized to a 0-100 point scale where higher values indicate less decisional regret. Scores will be compared between study arms.

  Up to 24 months after randomization

Secondary Outcomes (3)

• Decisional conflict

  24 months after randomization

• Treatment satisfaction

  24 months after beginning treatment

• Current health state utility

  24 months

Other Outcomes (1)

• Health Related Quality of Life (HRQOL)

  24 months after start of treatment

Study Arms (2)

Standard patient-physician counseling interaction

ACTIVE COMPARATOR

The control arm will receive counseling regarding treatment options using standard patient-physician interactions and nomogram-predicted probabilities of treatment outcome for the various treatment options and they will be unaware of the decision analysis recommendation.

Behavioral: Standard patient-physician counseling interaction

Personalized treatment recommendations

EXPERIMENTAL

The treatment arm would be provided with a personalized treatment recommendations based on the decision analysis model prior to treatment selection.

Behavioral: Personalized Treatment Recommendations; Behavioral: Standard patient-physician counseling interaction

Interventions

Personalized Treatment Recommendations BEHAVIORAL

This is a psychosocial/behavioral study. It will use a randomized trial to test the hypothesis that a decision analysis model that provides individualized estimates of quality-adjusted disease-free survival for each of the treatment options for clinically localized prostate cancer will lead to higher quality treatment decisions congruent with a patient's values leading to improved decisional regret and treatment satisfaction. In this trial, all patients would be evaluated at baseline for their utilities for various clinically important health states. The primary endpoint of this study will be regret-free survival at 2 years after treatment. There will be a 1:1 randomization. A random permuted design will be used to assure approximate balanced number of patients in the two groups over time.

Personalized treatment recommendations

Standard patient-physician counseling interaction BEHAVIORAL

Both patients and physicians will be unaware of the decision analysis recommendation and the patients will receive standard treatment counseling alone. After the patient has made a treatment decision he will be given a short questionnaire to assess decisional conflict. If after one month no treatment decision information is available, a letter and form requesting treatment information along with the decisional conflict questionnaire will be sent to patients.

Personalized treatment recommendations; Standard patient-physician counseling interaction

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to the Cleveland Clinic Foundation for the treatment of clinically localized prostate adenocarcinoma
• Ability to read English at a grade eight level

You may not qualify if:

• No other cancer diagnosis for the past 3 years, except for non-melanoma skin cancer
• Prior chemotherapy within the last 3 years
• Previous pelvic radiation therapy
• Previous pelvic surgery
• Neoadjuvant therapy prior to referral, such as hormones

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Andrew Stephenson, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

US (1)